FDA Grants RMAT Designation to ALLO-715 for Relapsed/Refractory Multiple Myeloma
April 21st 2021The FDA granted a Regenerative Medicine Advanced Therapy designation to the allogeneic chimeric antigen receptor T-cell therapy as a potential treatment for patients with relapsed/refractory multiple myeloma.
Deepu Madduri, MD, on the Design of the Phase 1b/2 CARTITUDE-1 Trial
January 12th 2021The goal of the CARTITUDE-1 study was to evaluate the use of ciltacabtagene autoleucel (cilta-cel; JNJ-68284528) chimeric antigen receptor T-cell therapy in heavily pretreated patients with relapsed or refractory multiple myeloma.
FDA Approval Sought for Cilta-Cel in Relapsed/Refractory Multiple Myeloma
December 21st 2020December 21, 2020 - A rolling submission of the biologics license application for the BCMA-directed CAR T-cell product ciltacabtagene autoleucel for use in adults with relapsed/refractory multiple myeloma has been initiated to the FDA.
Negrin Shines Light on the Orca-T Story in GVHD
December 7th 2020What started out as a journey to better understand regulatory T cells has now led to an intriguing approach with an investigational cell therapy designed to prevent the risk of graft-versus-host disease and to improve relapse-free survival rates in patients undergoing hematopoietic stem cell transplantation.
ALLO-715, Off-the-Shelf CAR T-Cell Therapy, Produces Early Promise in Multiple Myeloma
December 7th 2020An off-the-shelf CAR T-cell therapy that targets B-cell maturation antigen, ALLO-715, elicited responses in heavily pretreated patients with relapsed/refractory multiple myeloma in early findings from a first-in-human study presented at the 2020 ASH Meeting.